Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03971578
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2019-05-30
Brief Title:
Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
Sponsor:
Intelligent Hearing Systems
Organization:
Intelligent Hearing Systems
Study Overview
Official Title:
Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to develop an Auditory Brainstem Response ABR based neurological screening method to detect increased risk for Autism Spectrum Disorders ASD and other neurological conditions in newborns
Detailed Description:
In the proposed study a screening method for neurological deficits with an emphasis on its application to ASD will be developed and its feasibility demonstrated The proposed method will utilize high rate stimulation to acquire Auditory Brainstem Responses in order to determine peak latency and amplitude differences in children with ASD compared to non-ASD Similarly to newborn hearing screening the output of the screening method will provide an automated pass or refer outcome that can be used by a physician to determine if the child needs further evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None